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510(k) K974168

COOPERSURGICAL INFRARED COAGULATOR by Hogan & Hartson — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1998
Date Received
November 5, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

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  • K942389 — TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES (February 16, 1996)
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  • K946216 — CARDIOLIPIN A EIA TEST SYSTEM (January 24, 1996)
  • K946215 — CARDIOLIPIN G EIA TEST SYSTEM (January 24, 1996)
  • K946186 — CHAL-2500 (August 14, 1995)
  • K941566 — COMPUSPEAK (June 30, 1995)
  • K950110 — MARDX MITOCHONDRIA EIA TEST SYSTEM (May 15, 1995)

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